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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10604
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/19/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that deflation failure occurred.The target lesion was located in a coronary vessel.A 3.00x24mm synergy ii drug eluting stent was advanced for treatment.However, it was noted that the balloon would not deflate despite multiple attempts.The procedure was completed with another of the same device.There were no patient complications reported.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10971473
Report Number2134265-2020-17115
Device Sequence Number4295460
Product Code NIQ
UDI-Device Identifier08714729840237
UDI-Public08714729840237
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/08/2022
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0025737589
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/19/2020
Initial Report FDA Received Date12/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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